SYSMEX CA-1000/SYSMEX CA-5000

System, Multipurpose For In Vitro Coagulation Studies

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Ca-1000/sysmex Ca-5000.

Pre-market Notification Details

Device IDK964946
510k NumberK964946
Device Name:SYSMEX CA-1000/SYSMEX CA-5000
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
ContactMargaret Barranco, Ma, Mt (ascp)
CorrespondentMargaret Barranco, Ma, Mt (ascp)
SYSMEX CORP. GILMER RD. 6699 RFD Long Grove,  IL  60047 -9596
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-10
Decision Date1997-03-18
Summary:summary

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